Clinical Trial of Mycophenolate Versus Cyclophosphamide in ANCA Vasculitis

NCT00414128 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2013-12-06

No results posted yet for this study

Summary

The purpose of this study is to investigate whether mycophenolate mofetil is effective as treatment for new cases of ANCA associated vasculitis.

Conditions

  • Vasculitis

Interventions

DRUG

mycophenolate mofetil

2-3g/day for 3-6 months, in tablet, capsule or liquid form

DRUG

cyclophosphamide

intravenous cyclophosphamide, 15mg/kg with dose reductions according to age and renal function, for 3-6 months (6-10 doses total)

Sponsors & Collaborators

  • Aspreva Pharmaceuticals

    collaborator INDUSTRY
  • Vifor Pharma

    collaborator INDUSTRY
  • Cambridge University Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • David Jayne · Addenbrooke's Hospital, Cambridge, UK

  • Lorraine Harper · Birmingham University, UK

  • Rachel Jones · Addenbrooke's Hospital, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2011-07-31
Completion
2013-02-28

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00414128 on ClinicalTrials.gov